Multi-chamber, Multi-formulation Fluid Delivery System

ABSTRACT

The application discloses a multi-chamber, multi-formulation fluid delivery system, comprising a multi-chamber applicator in fluid communication with multi-chamber packaging. Applicators according to the instant disclosure have reduced squeeze-strength requirements, and are useful for dispensing fluids, including medicaments, to animals, including livestock animals. The multi-chamber packaging provides separate storage for formulations containing incompatible active ingredients, and is suitable for use with the multi-chamber applicator. The application also discloses methods for using the system to simultaneously deliver multiple active ingredients, at least some of which are not suitable for co-formulation, thus reducing the time, economic burden and animal stress involved with applying multiple, separate formulations to animals.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/488,968, filed on Sep. 17, 2014, which claims priority to U.S.provisional application No. 61/878,860, filed on Sep. 17, 2013, andherein incorporated by reference in its entirety. All other referencescited herein are likewise incorporated by reference herein in theirentirety.

FIELD OF THE INVENTION

The present invention relates to multi-chamber fluid delivery systemscomprising applicators, connecting means, and multi-chamber packaging.In particular, the invention relates to systems useful in deliveringliquid formulations, including medicaments and parasiticides, to animalsin need thereof.

BACKGROUND OF THE INVENTION

Animal remedies for sheep, cattle and other livestock/production animalsare applied by a number of methods including topical or “pour-on”application, oral “drench” application, injection and nasal infusion.Each of these administration routes is typically dispensed from a“pistol grip” style dispensing means. Such an applicator is described inthe applicant's New Zealand patent No. 521084, the contents of which areherein incorporated by reference.

Conventional fluid applicators have incorporated two, one-way valves(inlet and outlet). Such valves are typically biased with springs, sothat they open only when there is a predefined difference in the fluidpressure between the upstream side of the valve and the downstream side.Fluid cannot flow backwards through either valve, as flow in thisdirection will tend to push the valves more tightly closed.

When the applicator is at rest, both valves are closed. When theapplicator is in use, it is intended that only one valve opens at atime. During the discharge stroke, the outlet valve is pushed open bythe raised fluid pressure within the barrel. During the refill stroke,the inlet valve is pushed open by fluid entering the barrel (where thereis now a partial vacuum).

A problem with conventional applicators is that they require arelatively large force to squeeze the handles together during theapplication stroke of the piston. This may be fatiguing for theoperator, particularly when the applicator is used to treat a largegroup of animals. In response to this problem, Applicants developed theBREAZE™ Technology, which is fully disclosed in patent AU 2013100370,the contents of which are herein incorporated by reference it theirentirety. FIGS. 1-2 depict some of the key features of the BREAZE™applicator, which requires a significantly smaller amount of force tosqueeze as compared to predecessor dosing gun devices.

Although the BREAZE™ technology significantly improved upon “harder tosqueeze” prior art devices, it would be useful to build on thistechnology to develop an applicator which allows for the delivery of twoor more fluids. Such a device would allow for more efficient delivery offluids that must be stored separately (e.g. active ingredient substanceswhich are not readily co-formulated). Moreover, it would be desirable todevelop devices capable of delivering even larger volumes of fluid,while maintaining the low squeeze strength requirement of the original,single chamber, single formulations BREAZE™ applicators. Finally, toproduce acceptable ergonomics for such a device, it would be highlydesirable to reverse the applicator's configuration, such that thedosing chambers/barrels are situated above the users wrist instead of infront of the applicator.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a multi-chamber,multi-formulation fluid delivery system (hereinafter, “the System”),comprising a multi-chamber applicator in fluid communication with amulti-chamber package. The applicator has reduced squeeze-strengthrequirements, and is useful for dispensing fluids, includingmedicaments, to animals, including livestock animals. The multi-chamberpackaging provides separate storage for formulations containingincompatible active ingredients, and is suitable for use with themulti-chamber applicator.

It is another object of the invention to provide methods for using theSystem to simultaneously deliver multiple active ingredients, at leastsome of which are not suitable for co-formulation. For example, it iswell-known that Macrocyclic lactone parasiticides are particularlysensitive to acid hydrolysis, so combining them with water-solubleanthelmintics (e.g. levamisole) has been extremely difficult. In fact,co-formulation of some active ingredients has proved so challenging thatmany parasiticide/pesticide manufacturers have opted to supplyincompatible compounds as separate formulations/product offerings, eventhough simultaneous delivery is highly desired by customers. Theinventive simultaneous delivery methods offer a solution to this problemby providing both a financial advantage (i.e. reducing the time it takesto apply medicaments by more than half), and by providing a way toachieve an improved clinical effect (e.g. speed or duration ofparasiticidal/pesticidal activity), where simultaneous active ingredientdelivery is the only or best way to achieve such an effect. Moreover,simultaneous formulation delivery is less stressful to the animals thanseparate/sequential formulation delivery.

Other objects of the present invention may become apparent from thefollowing description, which is given by way of example only.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depicts a Multi-chamber, Multi-formulation Delivery Systemaccording to the disclosure;

FIG. 2A is a cross-section side view of a pressure limiting means andvalve means of a Multi-chamber Applicator according to the disclosure(valve closed);

FIG. 2B is the cross-section with the pressure limiting valve meansopen;

FIG. 3A depicts an applicator (200) according to the disclosure, whichcomprises the valve means and pressure limiting means depicted in FIGS.2A and 2B;

FIG. 3B is an exploded view of the applicator;

FIG. 3C is an exploded view of the nozzle of the applicator;

FIG. 3D contains multiple views of the applicator: front (I); back (II);left side (III); top (IV); and bottom (V);

FIG. 3E shows a top-bottom cross-section of the applicator (location ofthe section is marked in the accompanying left side view);

FIG. 3F shows a front-back cross-section of the applicator (location ofthe section is marked in the accompanying left side view);

FIG. 4 depicts an alternate embodiment of an applicator (201) accordingto the invention, wherein the dosage selector (71) immediately adjacentto the dosage indicator (70), instead of as depicted in FIG. 3A, wherethe dosage selector (71) circumscribes the central cylinder (76);

FIG. 5 is a schematic diagram depicting the operation and fluid flowpath of a multi-chamber applicator according to the instant disclosure;

FIG. 6A depicts an embodiment of the multi-chamber packaging, where twoseparate reservoir “halves” are designed to be brought together usingvessel/reservoir interlocks;

FIG. 6B depicts the two halves connected by the interlocks;

FIG. 7 depicts several features of one chamber (300) of a multi-chamberpackage according to the invention;

FIG. 8 depicts the configuration of the multi-chamber packaging duringshipping/transport (I); use (II-V); and storage (VI);

FIG. 9 depicts a no-twist, vented draw-off cap for use with themulti-chamber packaging;

FIG. 10 presents a multi-chamber packaging in its inverted position,shown with two vented draw-off caps and suitable hoses;

FIG. 11 depicts a dip tube assembly, for use with the packing in itupright position;

FIG. 12 presents a harness for the multi-chamber packaging;

FIG. 13 is a drawing of a person equipped with a multi-chamber,multi-formulation fluid delivery system according to the disclosure;

FIG. 14A is a front/right/top view of a multi-chamber applicator (203);

FIG. 14B is a left view of a multi-chamber applicator (203);

FIG. 14C is a top view of a multi-chamber applicator (203);

FIG. 15A is an exploded view of a portion of the applicator (203),showing the front-most (i.e. in the direction of the nozzle) of theapplicator;

FIG. 15B is an exploded view of a portion of the applicator (203),showing from the front of the nozzle to about the middle of theapplicator;

FIG. 15C is an exploded view of a portion of the applicator (203),showing from the middle of the applicator to the housing for thebarrels;

FIG. 15D is an exploded view of a portion of the applicator (203),showing the back-most end;

FIG. 16 is a cross-section of the applicator (203);

FIG. 17A is a cross-section of the applicator (203), showing the “doublestaircase” dosage regulator;

FIG. 17B shows the dosage regulator engaging with the two plungers ifthe depicted dual-chamber applicator;

FIG. 18A is a nozzle according to the disclosure, marked with thecross-section line corresponding to the cross-section depicted in FIG.18B;

FIG. 18B is the cross-section of the nozzle, which corresponds to themarking in FIG. 18A;

FIG. 19A is an alternate “open rose” nozzle, marked with thecross-section line corresponding to the cross-section depicted in FIG.19B;

FIG. 19B is the cross-section of the alternate “open rose” nozzle, whichcorresponds to the marking in FIG. 19A;

FIG. 20A is a drawing of a user, shown from the front, equipped with theapplicator and co-packaging (in the upright position) according to thedisclosure;

FIG. 20B is a drawing of a user, shown from the right side, equippedwith the applicator and co-packaging (in the upright position) accordingto the disclosure;

FIG. 21A is a drawing of a user, shown from the back, equipped with theapplicator and co-packaging (in the upright position) according to thedisclosure;

FIG. 21B is a drawing of a user, shown from the back, equipped with theapplicator and co-packaging (in the inverted position) according to thedisclosure;

FIG. 22A is a drawing of a harness for the co-packaging, showing thesurface that would be in contact with a user's back;

FIG. 22B is a drawing of a harness for the co-packaging, showing thesurface that would be visible when viewing a user (equipped therewith)from behind;

FIG. 23A depicts vented caps and anti-counterfeiting measures accordingto the disclosure;

FIG. 23B depicts cross-sections of vented caps and anti-counterfeitingmeasures according to the disclosure.

DESCRIPTION OF THE INVENTION

Throughout the description and the claims, all reference to pressuresare to gauge pressures, i.e. pressure relative to the ambient pressure.Therefore, a reference to zero pressure means ambient pressure.Reference to negative pressure means suction. Reference to a partialvacuum is any pressure below ambient pressure but greater than a totalvacuum.

Reference to the “upstream” direction is towards the direction in thefluid flow path from which fluid enters the applicator. Reference to the“downstream” direction is to the direction in which the fluid normallyflows.

The reference to any prior art in the specification is not, and shouldnot be taken as, an acknowledgement or any form of suggestion that theprior art forms part of the common general knowledge in any country.

According to one aspect of the present invention there is provided aMulti-chamber System comprising a multi-chamber applicator andmulti-chamber packaging.

In an embodiment, the applicator comprises:

-   -   at least two fluid supply inlets;    -   at least one outlet;    -   at least two barrels each having barrel outlets and barrel        inlets which are in fluid communication, or selective fluid        communication, with the fluid supply inlets;    -   at least two one way outlet valves, one for each barrel, in        fluid communication with the barrel outlets and with the        outlets;    -   at least two pistons, one for each barrel, moveable relative to        the barrels and in sealing engagement with the barrels;    -   a piston actuation means for moving the pistons relative to the        barrels;    -   at least two pressure limiting means for limiting a maximum        pressure of fluid entering the barrels from the fluid supply        inlets;    -   a means for combining the fluids from the at least two barrels        into a single outlet.

In a particular embodiment, the applicator further comprises a means forselecting the volume of fluid that is drawn into each barrel from areservoir, contained within a multi-chamber active ingredientformulation package.

In an embodiment, the pressure limiting means is configured such thatthe fluid entering the barrels has a pressure which is at or below anambient atmospheric pressure.

In another embodiment, the pressure limiting means is configured suchthat the fluid entering the barrels has a pressure which is at or belowa pressure required to open the outlet valves.

In an embodiment, the pressure limiting means are provided at oradjacent the barrel inlets.

In an embodiment, the pressure limiting means are fixed at the entranceor base of the barrels.

In a particular embodiment, the pressure limiting means comprisediaphragms.

In an embodiment, each diaphragm is annular in shape. A first side ofeach diaphragm may be in fluid communication, or selective fluidcommunication, with fluid in each barrel. In such an embodiment, eachopposite second side of each diaphragm is exposed to ambient atmosphericpressure.

In an embodiment, displacement of the diaphragm changes an internalvolume of a conduit supplying fluid to the barrel inlets.

In a particular embodiment, the applicator is provided with a one wayvalve means for preventing fluid flow from each barrel though itsrespective barrel inlet.

In an embodiment, the pressure limiting means is adapted to preventfluid flow from the barrel inlet to the fluid supply inlet.

Each barrel's corresponding pressure limiting means may comprise a firstvalve head and a first valve seat, wherein the first valve head can bemoved from a closed position to an open position by movement of thediaphragm. In a particular embodiment, each pressure limiting meanscomprises a second valve head and second valve seat, wherein the secondvalve head is connected to the first valve head and moves with the firstvalve head. In such an embodiment, a pressure difference across saidfirst valve head is substantially equal to a pressure difference acrosssaid second valve head.

In a particular embodiment, the pressure difference across said firstvalve head creates a resultant force in a first direction and thepressure difference across said second valve head creates a resultantforce in a second direction which is opposite to the first direction.

In an embodiment, the resultant forces are substantially equal, for eachbarrel.

In an embodiment, the resultant force on the second valve head isgreater than the resultant force on the first valve head, for eachbarrel.

According to another aspect of the present invention there is provided aMulti-chamber, Multi-formulation Delivery System (hereinafter “theSystem”) comprising an applicator and at least two fluid supply conduitswith required connectivity, and a Multi-chamber, Multi-formulationPackaging, comprising multiple independent fluid reservoirs filled withformulations. In a particular embodiment, the formulations contain oneor more active ingredients, which cannot be combined into a single,shelf stable formulation.

According to a further aspect of the present invention there is provideda Multi-chamber, Multi-formulation Delivery System substantially asherein described with reference to any one of FIGS. 2 to 8. Theinvention may also be said broadly to consist in the parts, elements andfeatures referred to or indicated in the specification of theapplication, individually or collectively, in any or all combinations oftwo or more of said parts, elements or features, and where specificintegers are mentioned herein which have known equivalents in the art towhich the invention relates, such known equivalents are deemed to beincorporated herein as if individually set forth. Further aspects of theinvention, which should be considered in all its novel aspects, willbecome apparent from the following description given by way of exampleof possible embodiments of the invention.

The invention will now be described in the following non-limitingExamples.

EXAMPLES Multi-Chamber, Multi-Formulation Fluid Delivery System

In a particular embodiment, the invention provides a Multi-chamber,Multi-formulation Delivery System (hereinafter “the System”),substantially as depicted in FIG. 1.

In an embodiment, the System comprises:

-   -   (a) a multi-chamber applicator for delivering multi-formulations        to an animal;    -   (b) suitable conduit and connectivity for connecting the        applicator to fluid packaging; and    -   (c) multi-chamber package for separately containing and storing        formulations.

In a particular embodiment, the applicator is substantially as depictedin FIGS. 3 and 5, and as described below. The applicator may beconnected to the multi-chamber packaging by conduits, which arecolor-coded (or otherwise marked) to reduce the chance of combiningincompatible formulations in the connecting conduits or the applicatorchambers.

Multi-Chamber Applicator

Referring to FIGS. 2A, 2B, 3A-D and 5, an applicator according to oneembodiment of the present invention is generally referenced by arrow200. Hereinafter, whenever the disclosure refers to numericalidentifiers for the various Figures, “a” shall refer to the componentspresent in the chamber assembly depicted in the lower portion of FIG.3A, while “b” shall refer to the corresponding “twin” component depictedin the upper portion of FIG. 3A. Where not explicitly stated, it isintended that reference to any component that is present in both the “a”and “b” barrel assembly, “#” shall be understood to mean “#a/b.” Forexample, reference to “conduit 13” shall be understood to be equivalentto reference to “conduit 13 a/b.” Moreover, in reading this disclosure,an ordinarily skilled person will instantly be able to produce a devicewith two (a/b), three (a/b/c), four (a/b/c/d), five (a/b/c/d/e), six(a/b/c/d/e/f), or any higher number of barrel assemblies, without theexertion of inventive activity. The inventors also envision applicatorsthat do not mix the two or more formulations in advance of the fluidstreams making contact with a target patient/animal. For example, themulti-chamber applicator may have more than one outlet, including two,three, four, or any higher number of outlets. Such a configuration wouldbe highly advantageous where the two or more formulations are soincompatible that mixture of same prior to release from the applicatorcould cause unacceptable clogging, corrosion, or other types of damagedispensing conduits.

In the embodiment depicted in FIG. 3A, the applicator 200 has a firstbarrel (1 a) with an outlet (2 a). A one way outlet valve (3 a) isprovided at or adjacent the barrel outlet (2 a). The barrel outlet (2 a)is in selective fluid communication with an applicator outlet (4) fromwhich fluid is discharged in use. In other embodiments (not shown) theone way valve (3 a) may be integrated with the valve means (12 a).Correspondingly, the applicator has a second barrel (1 b) with an outlet(2 b). A one way outlet valve (3 b) is provided at or adjacent thebarrel outlet (2 b). The barrel outlet (2 b) is in selective fluidcommunication with an applicator outlet (4) from which fluid isdischarged in use. In other embodiments, the one way valves (3 a/b) arelocated at the connection between the nozzle and the applicator, at theend of the conduits (75 a/b) (i.e. at point “X” in FIG. 5). Theapplicator could also have additional barrels, wherein the “nth” barrel(1 x) with an outlet (2 x). A one way outlet valve (3 x) is provided ator adjacent the barrel outlet (2 x). The barrel outlet (2 x) is inselective fluid communication with an applicator outlet (4) from whichfluid is discharged in use, wherein “n” is an integer greater than 3 and“x” is a small letter c-z.’

In a particular embodiment, the fluids combine once they have passed thetwo one-way valves, (3 a/b). In another embodiment, the fluid streamsmay combine just prior to exiting the applicator (200) at the outlet(4).

A piston or plunger (5) is located within the corresponding barrel (1)and has corresponding sealing means (6), for example an O-ring seal, tosealingly engage a corresponding inner surface (7) of the barrel (1).

In an embodiment, the piston (5) is connected to or has an integratedpushrod (8) and a substantially cylindrical head (9) that travel alongthe cylindrical barrel. When the handle (32) is squeezed, the pushrodmoves the piston along the cylindrical barrel (1) such that the distancebetween the head of the piston (5) and the valve means (12) is reduced.When the handle (32) is released, this distance increases. Initialsqueezing of the handle (32) prepares the applicator (200) for receivingfluid into each of its chambers/barrels (1). Releasing the handle (32)causes fluid to be drawn through the valve means (12) into the barrel(1). Alternatively, each barrel may be individually primed by pressingand releasing each of the barrel plungers. Subsequent squeezing of thehandle (32) dispenses the fluid by forcing it to pass through theone-way valve (3), through the barrel outlet (2), and into thedispensing conduit (75). The two dispensing conduits (75 a/b) may meet(e.g. at a “Y” junction) to combine the fluids just prior to exiting theapplicator (200) via the outlet (4). Alternatively, the conduits (75a/b) may remain separate, terminating into two separate dispensing tips,instead of combining at point “X” as shown in FIG. 5.

Fluid travels to each applicator barrel (1) via a filling conduit (76),which is removably attached to an inlet (14). From the inlet (14) thefluid enters the barrel (1) through a pressure limiting means (10) andthe valve means (12), as depicted in FIGS. 2A (valve closed), 2B (valveopen), 3 and 4. In an embodiment, the pressure limiting means (10)comprises a flexible diaphragm (11) connected to the valve means (12).In the embodiment shown, a one way valve means (15 a) is provided toprevent flow from the barrel (1) towards the inlet (14).

In this embodiment the outlet valve (3) is of a type commonly known asan umbrella valve, selected because of its ability to open at relativelylow pressure and therefore reduce the squeeze force required to beapplied to handle (32). A valve incorporating a spring could be usedinstead, as could any other reasonable valve known to those of skill inthe art. In this embodiment the one way valve (15 a) is a valve discwhich is held in place by a pin (52). Rigid tubing (77) connecting theinlet (14) to the barrel (1) comprises a jet component (53), whichdefines an orifice 54 for fluid to flow into the pressure limiting means(10) and the valve means (12).

An annular diaphragm (11) is clamped to the tubing (77) by a clamp ring(58), held in place by integral clips (59). The clips 59 pass throughapertures (30) in the base of the tubing, where the tubing meet the baseof the barrel (1). These apertures (30) also provide venting to one sideof the diaphragm (11).

A force transfer component (55) has an outer ring or hub (18), which is(in FIG. 2A/2B) separated from the diaphragm (11) by clearance space(31). The force transfer component (55) has multiple spokes (20) whichconnect the outer hub (18) to an inner portion (56) which carries asealing washer (57).

A spring (29) biases the force transfer component (55) and the sealingwasher (57) against the jet (53), blocking the orifice (54). In this waythe sealing washer (57) functions as a valve head (22), and the end ofthe jet component (53) functions as a valve seat (24). A plurality ofradially inwardly extending fins (60) define a guide for the spring (29)and the force transfer component (55). The fins (60) may also limit themaximum travel of the force transfer component (55), when the outer rim(18) contacts the fins (60). In this way the fins (60) may limit theopening of the sealing washer (57) from the jet component (53), therebylimiting the flow rate of fluid (61) travelling through the inletconduits into the barrel. By limiting this flow rate, the magnitude ofthe pressure pulse created at the end of the refilling stroke islimited.

The use of the diaphragm (11) to provide an opening force on the sealingwasher (57) means that the spring (29) can be configured to provide arelatively high closing force, thereby reducing the likelihood that thepressure pulse created when the piston reaches the end of the refillingstroke will pass into and through the barrel. The ability of thediaphragm itself to deflect (effectively increasing the volume of theinlet conduit), thereby absorbing any small amount of fluid which thepressure pulse does force past the pressure limiting means valve head,also reduces the likelihood that fluid will leak from the outlet valve,even if the fluid pressure required to open the outlet valve is lowcompared to the applicators of the prior art.

The force of spring (29) is sufficient to hold valve (12) closed againstthe pressure of the fluid in the rigid tubing (77), even if the fluidreservoir (see FIG. 1 and below description of the Multi-chamberpackaging) which supplies fluid to the fluid inlet (14) is raised alimited distance above the applicator (200).

When the user operates the actuating means (32) to drive the piston (5),the piston 5 is pushed backwards, towards the user's body, and displacesfluid which flows through the one way outlet valve (3). The multiplestreams of fluid then flow through the dispensing conduits (75), combineat the dispensing conduit junction (80), and exit out through the outlet(4). The force required to open the outlet valve (3) causes the pressureinside the barrel (1) to rise above atmospheric pressure. The one wayvalve (15 a) prevents this pressure from pushing the diaphragm (11)rearwards. The diaphragm (11) does not move from the position shown inFIG. 2A during this phase of operation. Valve (12) is still held closedby spring (29). In particular embodiments, the outlet valve (3) isconfigured to open under a lower pressure than the outlet valves ofconventional applicators. This reduces the pressure of the fluid withinthe barrel during the application stroke, and hence reduces the requiredhand squeeze force on the handle (32).

When the user releases the handle (32), a biasing means, for example apiston spring (40) provided circumscribing the piston (5), pulls thepiston (5) forwards. This induces a partial vacuum inside the barrel(1), which is communicated to the diaphragm (11) through the inlet (15)and one way valve (15 a). Air pressure acting on the rearward-facingside of the diaphragm (11) pushes the diaphragm forwards, closingclearance space (31). The diaphragm (11) then pushes forwards againstthe force transfer component (55). When the pressure of the fluid in thebarrel (1) is low enough, the force generated by the diaphragm (11)overpowers the spring (29) and moves the valve head (22) away from thevalve seat (24), as shown in FIG. 2B, thereby allowing fluid to flowthrough the valve (12).

The distance that the valve (12) opens depends (amongst other things) onhow low the pressure in the barrel (1) is. The valve (12) may openfully, or only part-way. In some embodiments, the stiffness of thediaphragm (11) may cause it to act like a spring, adding to the biasingforce created by spring (29).

FIG. 2B shows the assembly with the diaphragm (11) deflected and thevalve (12) fully open. This occurs when the piston (5) is beingretracted and the barrel (1) is filling with fluid through the valve(12) and inlet (15). At the end of the barrel refilling stroke thepiston (5) contacts a fixed stop. The stop is typically part of avariable dosage control means (71). Suitable dosage control means areknown to the art, and include that described in applicant's New Zealandpatent number 521084, the contents of which are included herein byreference.

The momentum of the fluid flowing into the force limiting means (10) andvalve (12) via rigid tubing (77) and in the upstream supply tube (76,depicted in FIGS. 1 and 5) may tend to keep the fluid moving past thevalve (12) and into the barrel (1), even though the spring (29) isacting on the valve head (22) to try to close the valve (12). If thisoccurs, the pressure in the barrel (1) rises and the diaphragm (11)moves rearward, pulled back by the spring (29) acting on the diaphragmvia the force transfer component (55).

The valve (12) returns to its substantially closed position before therising pressure in the barrel (1) reaches atmospheric pressure. Closureof the valve (12 a) may result in a pressure pulse (from a “waterhammer” effect, which is known to those of skill in the art) in thetubing (77), and the preceding supply tubing (76). However, the force ofthe spring (29) is ideally sufficient to keep the valve (12)substantially closed despite the momentary increase in pressure causedby the pressure pulse.

Since the pressure pulse cannot pass the closed valve (12), the problemof fluid discharging from the nozzle during this time is avoided. Sincethe valve (12) is opened by the diaphragm (11) when necessary, thespring (29) may be selected to provide a larger biasing force than thatused by the applicators of the prior art. Assuming that there are noleaks, the pressure in the barrel (1) remains slightly below atmosphericpressure. Because no more fluid can pass the closed valve (12), thediaphragm (11) may remain deflected slightly forwards, touching theforce transfer component (55) (i.e. the clearance space (31) is closed).

Those skilled in the art will appreciate that although the pressure inthe barrel (1) of the embodiment described above is below atmospheric atthe end of the inlet stroke, other embodiments may be configured suchthat the pressure is at or above atmospheric pressure at that stage. Inparticular, the water hammer pressure pulse may be large enough to forcea small volume of fluid past valve (12), preventing the valve fromclosing fully, or even reopening it slightly, despite the biasing forceof the spring (29). The passage of this small volume of fluid willdisplace the diaphragm rearward, reopening a gap between the forcetransfer component (55) and the diaphragm (11). There may be acorresponding rise in the pressure of the fluid in the barrel. Whilethis pressure rise may be mitigated by the increase in available volumecaused by the deflection of the diaphragm, in some circumstances thepressure may rise to above atmospheric pressure. However, as long as thepressure within the barrel is not high enough to force the outlet valve(3) open, there will be no unwanted discharge of fluid. Therefore, theideal applicator should have substantially zero, or zero unwanteddischarge of fluid.

In a particular embodiment of the invention, the fluid flows inaccordance with the drawings in FIG. 5. The general flow of fluid duringtypical applicator operation is as follows:

1. Set Dose, Ready the Applicator to Prime—the dose is selected usingthe dosage selector (71), and the handle is then pulled back to bringboth plungers to full extension (regardless of dose setting);

2. Fill Dual Chambers—the handle is released and both plungers (5)retract, creating a vacuum in the dose chambers/barrels (1). Fluidenters both dose chambers through the BREAZE™ twin-valving.Alternatively, the plungers may be pressed back individually, usingthumb/finger tabs (72), to fill the chambers/barrels (1);

3. Ready to Use—the plungers (5) are fully retracted and both dosechambers (1) are filled to the selected dose;

4. Pour-on Application—the handle (32) is pulled back and fluid isexpelled from both dose chambers first through the outlet valves (3),then into the dispensing conduit (75), and finally out the outlet (4).The fluid streams are combined at junction (80) just prior to exitingthrough outlet (4);

5. Oral Dose Applied—the handle is pulled back and both plungers are atfull extension (regardless of dose setting). The combined product fromboth dose chambers has been dispensed through alternate oral-deliverynozzle (not shown here, but easily added/adapted by those skilled in theart).

The process is repeated as needed by cycling through either Stages 2 to4 (for topical application) or Stages 2, 3, and 5 (for oral delivery).

Multi-Chamber Packaging

In a particular embodiment, the Multi-chamber Packaging is as depictedin FIGS. 1, 6A/6B and 7.

In an embodiment of the multi-chamber packaging shown in FIG. 6B, twoseparate reservoir “halves” have been designed to be brought togetherusing vessel/reservoir interlocks (306). The embodiment shown in FIG. 7is one half of a dual-chamber package. The chamber may have a slot (301)that serves as a handle or an attachment for backpack-securing straps.Slot (302) may also serve as an attachment for straps. The chambers maybe equipped with travel/transit caps (304), which may be connected todispenser caps (305).

In an embodiment, a chamber may comprise a tether (308), which securesthe transit cap (305) to the packaging neck (307). Ideally, the transitcap (305) rotates freely within the tether ring (309), allowing the twotransit caps to be removed or secured to the packaging without twistingthe tethers and/or the conduits (76).

In a particular embodiment, each chamber includes a tamper evident ring,which breaks free from the transit cap (305) when transit cap is removedfrom the packaging.

The packaging may comprise 5 L vessels, hollow-section carry handles,four-point lugs (2 top+2 bottom) for securing the multi-chamberpackaging to a user's back with a simple strapping system or aco-packaging harness according to the instant disclosure.

In an embodiment, manufacturing data is provided on each vessel base,including a mold ID, a recycling symbol, and a date stamp. The transitcap may be, for example, 38 mm (one per vessel), and include: a tamperevident induction foil seal and a tether.

In an embodiment, two injection molded ‘H’ clips secure the two or morevessels/chambers together. Clips may be hidden by a product label, whichprovides a tamper evident seal.

In an embodiment, each chamber includes an induction foil seal (310),which provides both hermetic seal and secondary tamper evidence wheninduction sealed to the packaging neck.

In an embodiment, the packaging may be used according to schemepresented in FIG. 8:

-   -   1. “Shipping Mode”—Tamper evident transit caps fitted to each        chamber of the multi-packaging and induction sealed during;    -   2. Removing transit cap ruptures the tamper evident seal A    -   3. Foil seal B can now be removed.    -   4. Discard tamper evident ring A and remove foil seal B.        Packaging now opened.    -   5. Attach the No-Twist Vented Draw-Off Cap C and delivery tube D        to packaging. Transit cap remains tethered to packaging neck.    -   6. Re-attach transit cap to packaging. If the tamper evident        ring has been ruptured/removed, the transit cap has been        previously removed.

In an embodiment, the cap body provides connection for the delivery tubeand a fluid-tight seal to the packaging. Being separated from the CapLocking Ring, the Cap Body is not subjected to a twisting action whenthe locking ring is used to secure or remove the No-Twist Draw-Off Capto/from the packaging. The cap locking ring may fit over the cap bodyand engage with the packaging neck thread, securing the no-twistdraw-off cap to the packaging.

In an embodiment, the packaging includes a draw-off cap (no-twist andvented) substantially as depicted in FIG. 9. Component parts include:

-   -   1. A delivery tube, which provides a flexible interconnection        between the No-Twist Draw-Off Cap and the Applicator barrel;    -   2. A Cap Locking Ring, which fits over the Cap Body and when        engaged with the packaging neck thread, secures the No-Twist        Draw-Off Cap to the packaging ready for use. The draw-off tube        connection is not subject to a twisting action, allowing the        delivery tube to remain attached to the No-Twist Draw-Off Cap        when it is secured to or removed from the packaging.    -   3. A Cap Body, which provides the delivery tube connection to        the No-Twist Draw-Off Cap. The body may comprise a dual 6.4/9.5        mm delivery tube connection, and a cone seal, which provides        fluid seal between the No-Twist Draw-Off Cap and the packaging;    -   4. An Air bleed valve, which allows the co-packaging pressure        (vacuum) to equalize with the atmosphere when the product is        being removed during application; and    -   5. Optionally, an O-ring, which can be fitted inside the Cap        Body cone seal for additional fluid sealing provision.

In an embodiment, the packaging is used in its upright position, asdepicted in FIG. 1. In another embodiment, the packing is used in itsinverted position, as depicted in FIG. 10. To use the packaging in itupright position, a user may insert a Dip Tube Assembly (FIG. 11) intothe base of the No-Twist Draw-Off Cap. The User may remove the Dip TubeAssembly when using the packaging inverted. The No-Twist Draw-Off Capand the Dip Tube Assembly may be supplied with the Applicator.

In an embodiment, the System includes a harness for the multi-chamberpackaging, substantially as depicted in FIG. 12. A back mounted harnessmay contain single or multi-chamber packaging in the upright or invertedconfigurations, providing optimum comfort and user convenience.

In a particular embodiment, the harness is designed for use with a 10 Ltwin co-packaging. In other embodiments, the harness may be used withany other configuration of the multi-chamber packaging.

The harness may accommodate upright or inverted packaging, and it shouldbe quick and intuitive for a user to load or replace the multi-chamberpackaging. Optional attachments may include an applicator hook and apocket for containing, for example, a cell phone or other communicationdevice.

Methods for Simultaneously Delivering Two or More Formulations

As indicated above, many veterinarily important active ingredients arenot easily co-formulated, and so must be deliveredseparately/sequentially. The inability to deliver effective AIsimultaneously places a great economic burden upon those wishing totreat large numbers of production animals, including bovines, ovines,and caprines. The System of the present disclosure cuts the time andexpense of delivering incompatible active ingredients by more than half,for at least two important reasons. First, a single application willtake about half as long as a double application. Second, two separate AIformulations are typically less expensive than the corresponding dualformulation, if such an AI combination is even available. And finally,the development of resistance among parasites and pests has necessitatedthe used of multiple classes of active ingredients, which all butensures those who raise animals must incur the expense of multipleformulation applications.

Thus, in a particular embodiment, the invention provides a method forsimultaneously delivering at least two formulations, which contain atleast one active ingredient that is not stable, soluble, or otherwisecompatible with at least one other active ingredient.

In an embodiment, the invention provides a method for simultaneouslyadministering to an animal in need thereof multiple active ingredientformulations comprising the steps of:

-   -   a. connecting a multi-chamber applicator to multi-chamber        packaging containing, each of its chambers containing a separate        formulation;    -   b. loading or priming the multi-chamber applicator with the        separate formulations; and    -   c. actuating the applicator to dispense the formulations onto or        into the animal, thereby administering the active ingredients.

In an embodiment, a first formulation contains at least one activeingredient that cannot easily be co-formulated with at least one of theactive ingredients present in a second formulation.

In another embodiment, there is no known stable and effectiveco-formulation of the active ingredients.

In yet another embodiment, the simultaneous administration provides astronger or synergistic effect, when compared to the effect achievedwhen the one or more formulations is administered via separateapplications.

In an embodiment of the method, one active ingredient is fipronil andanother active ingredient is amitraz. Alternatively, one of the activeingredients may be a macrocyclic lactone, while the other activeingredient is levamisole or fluazuron. Many combinations will beappreciated by those skilled in the art of formulating activeingredients for veterinary and pharmaceutical applications. Thus,applicants envision that any combination of active ingredients that hasbeen recalcitrant to co-formulation may be more effectively andsimultaneously applied (as separate formulations) using the System ofthe instant disclosure. In a particular embodiment of the method, thesimultaneous administration of fipronil and amitraz has a stronger orsynergistic pesticidal effect as compared to a separate administrationof fipronil and amitraz.

In another embodiment, the stronger effect is extended duration ofefficacy against acarids, more rapid killing efficacy against acarids,reduced development of pesticide resistance, or any combination thereof.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise”, “comprising”, and thelike, are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense, that is to say, in the sense of“including, but not limited to”.

By “animal” is intended mammals, birds, and the like. Animal or host asused herein includes mammals and human. The animal may be selected fromthe group consisting of equine (e.g., horse), canine (e.g., dogs,wolves, foxes, coyotes, jackals), feline (e.g., lions, tigers, domesticcats, wild cats, other big cats, and other felines including cheetahsand lynx), ovine (e.g., sheep), bovine (e.g., cattle), porcine (e.g.,pig), avian (e.g., chicken, duck, goose, turkey, quail, pheasant,parrot, finches, hawk, crow, ostrich, emu and cassowary), primate (e.g.,prosimian, tarsier, monkey, gibbon, ape), ferrets, seals, and fish. Theterm “animal” also includes an individual animal in all stages ofdevelopment, including newborn, embryonic and fetal stages.

Unless otherwise explained, all technical and scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which this disclosure belongs. The singular terms“a”, “an”, and “the” include plural referents unless context clearlyindicates otherwise. Similarly, the word “or” is intended to include“and” unless the context clearly indicate otherwise.

Where in the foregoing description, reference has been made to specificcomponents or integers of the invention having known equivalents, thensuch equivalents are herein incorporated as if individually set forth.

EXAMPLES Example 1

In an embodiment, the applicator comprises the parts as shown in FIG.3B, and as recited in Table 1 below.

TABLE 1 Constituent components of the Applicator (200) depicted in FIG.3B. The numbering of the components applies only to this embodiment(i.e. applicator 200), unless otherwise expressly stated. FIG. 3A NumberQuantity Description 1 1 Delivery Tube Connector 2 2 O-Ring 3 2 InletNut 4 2 BREAZE ™ Inlet Assembly 5 2 O-Ring 6 2 Barrel Nut 7 4 O-Ring 8 2Barrel 9 2 O-Ring 10 2 Felt Washer 11 2 Plunger 12 2 Volume Control 13 2Toothed Wheel 14 2 Plunger Spring 15 2 Plunger Latch 16 1 OutletManifold (Rear Half) 17 1 Outlet Manifold (Front Half) 18 2 Outlet Tube19 1 Rear Handle 20 1 Dose Display Belt 21 1 Outlet Support 22 1 Cover23 1 Front Handle 24 1 Female Pivot Pin 25 1 Male Pivot Pin 26 1 DoseAdjuster 27 1 Outlet Adapter 28 6 Screw 29 1 Outlet Tube Connector 30 2Gasket 31 1 Nozzle Nut 32 1 Dual Chamber Nozzle 33 1 Outlet Valve Seat34 2 Outlet Valve 35 1 Nozzle Tip

Accordingly, an applicator according to the disclosure may comprise thefollowing: Delivery Tube Connector (1), O-Ring (2), Inlet Nut (3),BREAZE™ Inlet Assembly (4), O-Ring (5), Barrel Nut (6), O-Ring (7),Barrel (8), O-Ring (9), Felt Washer (10), Plunger (11), Volume Control(12), Toothed Wheel (13), Plunger Spring (14), Plunger Latch (15),Outlet Manifold (Rear Half) (16), Outlet Manifold (Front Half) (17),Outlet Tube (18), Rear Handle (19), Dose Display Belt (20), OutletSupport (21), Cover (22), Front Handle (23), Female Pivot Pin (24), MalePivot Pin (25), Dose Adjuster (26), Outlet Adapter (27), Screw (28),Outlet Tube Connector (29), Gasket (30), Nozzle Nut (31), Dual ChamberNozzle (32), Outlet Valve Seat (33), Outlet Valve (34), Nozzle Tip (35),

In a particular embodiment, all the parts are connected as indicated inFIGS. 3A-E.

Now that the disclosure has been made, the inventors envision that theapplicator (200) may comprise all the above-recited parts (1-35), or anycombination thereof, including any obvious equivalents thereof, providedthat the applicator functions in substantially the same way as theapplicator depicted in FIGS. 14A-C and 15A-D.

Example 2

In an embodiment, the applicator (203) comprises the parts as shown inFIG. 15A-D, and as recited in Table 2 below. The numbering of thecomponents applies only to this embodiment (i.e. applicator 203), unlessotherwise expressly stated.

TABLE 2 Constituent components of the Applicator (203) depicted, forexample, in FIGS. 14A-C and 15A-D. FIG. 15A-D Part Name Description 1Front handle Squeeze to discharge. 2 Plunger Normally the pin is engagedwith the vertical slot near the front of the engagement correspondingplunger shaft (29, 30). Pulling the knob out disengages that pin plungerfor one squeeze. This allows the opposite side to be primed further 3Spring without discharging fluid unnecessarily from the disengaged side.The spring 4 Knob (3) causes the pin to automatically re-engage theplunger shaft when the front handle (1) returns to its forward position.5 Rear handle This is the “fixed handle” for the applicator. Inpractice, both the front and rear handles move towards one another whenthe handles are squeezed. The rear handle may move less than does thefront handle. 6 Thread insert These metal components screw into theplastic rear handle (5) to provide anchor points for the tie rods (39).7 Housing This is attached to the rear handle (5) by the four screws(46). It guides the plunger shafts (29, 30) and the volume control (11).It provides structural support for the nozzle assembly. The housing (7)may also be integral with the rear handle (5), as one molded part. 8Thread insert These metal components screw into the plastic rear handle(5) to provide anchor points for the screws (46). 9 Pivot pin These pinsprovide the pivot point between the front and rear handles (1, 5).(male) 10 Pivot pin (female) 11 Volume The ribs at the front provide agrip for turning the volume control/dose control, or adjuster. Text (notshown) giving the dose size in mL is printed around the Dose component(where the arrowhead is positioned on the drawing). This text isadjuster visible through the small window on the top front of thehousing (7). The volume control has two spiral staircases wrapped aroundits outer surface. These staircases are positioned at differentdiameters, and offset slightly axially. The inner (and slightlyrearward) staircase engages with a rib on the left-hand plunger shaft(30), limiting how far forward this plunger shaft can travel. The outer(and slightly forward) staircase engages with a rib on the right-handplunger shaft (29), limiting how far forward this plunger shaft cantravel. The ribs on the plunger shafts (29, 30) extend radially inwardsby different lengths, determining which spiral staircase each of themengages with. The axial positions of these ribs on the plunger shaftsalso differ between the left and right plunger shafts (29, 30). The ribpositions are such that the two plunger shafts (29, 30) have the sameaxial position when in their forward position against the spiralstaircases, despite engaging with opposite sides of the volume control(11). Note that it may be generally necessary to squeeze the handles (1,5), moving the plunger shafts (29, 30) rearwards, before rotating thevolume control (11) in order to change the dose setting. 12 BarrelTransparent. This forms the two chambers (barrels) for pumping thefluid. component The one molding integrates the left- and right-handbarrels, the outlet tubes (on top) for carrying the fluid forwardtowards the nozzle, and two guide tubes for the tie rods (39) that holdthe assembly together. When the barrel component (12) is engaged withthe rear handle (5), the outlet tubes engage with the two elbowconnectors (41). 13 Fluid inlet These components make up the BREAZE ™valve assembly. 14 BREAZE ™ In the instantly depicted DUAL-BREAZE ™version, the fluid inlet (13) is valve housing equivalent to the plungershaft of the original technology disclosure (i.e. 15 Diaphragmsingle-chamber dosage device), but is now fixed in place. The hose barbsat its 16 Inlet valve rear end may be removed and replaced by snap-fitconnectors, as desired. 17 Inlet valve The BREAZE ™ valve housing (14)replaces the plunger head of the original retention pin single chamberBREAZE ™ delivery device. It has a tear-drop shaped flange 18 Clamp ringthat seals into the barrel (12) with fixed O-ring seal (24). Thistear-drop shape 19 Follower allows fluid to be directed to the fluidoutlet tubes that are integral with the 20 Jumper top of the barrel(12). washer 21 Spring 22 Jet 23 Plug Required to plug the hole in theside of the fluid inlet (13). 24 O-ring seal 25 Rear cover Holds thefluid inlets (13), the BREAZE ™ valve assemblies and the barrel in place(using the tie rods (39)). 26 Plunger head In an embodiment, theconnection between the plunger head (26) and the plunger shaft (29, 30)may be self-aligning. That is to say, they would move together axially,but the plunger head (26) would be free to move slightly in a lateralplane. This would allow it to self-align with the barrel bore, withoutany side loads from the plunger shaft endangering its seal with thebarrel wall. Such self-alignment is envisioned by the currentdisclosure, and would serve to accommodate manufacturing tolerances. 27Plunger O- Seals the plunger head (26) to the wall of the barrel (12).This is a sliding seal. ring 28 Felt washer Soaked in oil to lubricatethe bore of the barrel (12) with each stroke. 29 Plunger shaft Theplunger shafts (29, 30) slide inside the housing (7); one on each side.The (right hand vertical groove near the front of the plunger shaft (29,30) engages with the side) plunger engagement pin (2), so that theplunger shaft is moved by the front 30 Plunger shaft handle (1). (lefthand The part of the plunger shaft in front of the vertical grooveshould protrude side) farther outwards than is shown. This is to preventthe plunger engagement pin (2) from moving forward of the verticalgroove, even when the pin is in the retracted position. The plungerengagement pin (2) can be retracted and then slide back along the sideof the plunger shaft (29, 30), but not forward of it. The two plungershafts (29, 30) are not identical. The inwardly protruding ribs thatengage with the volume control (11) are different lengths radially andin different positions longitudinally. This is to ensure that eachengages with the correct spiral on the volume control (11), and bothplunger shafts (29, 30) stop in the same longitudinal position despiteengaging with opposite sides of the volume control (11). 31 OutletConnects the nozzle assembly structurally to the housing (7), by meansof adaptor screws (46). 32 Outlet tube The back end of the outlet tubeconnector (32) receives the two outlet tubes connector (45). The frontend seals to the nozzle (33) by means of one of the gaskets (34). 33Nozzle The nozzle has a vertical wall down its center, maintainingseparation of the two fluid paths. 34 Gaskets For sealing joints.(multiple places) 35 Outlet valve The outlet valve seat (35) supportsthe two umbrella valves (36). The valve seat mounting surfaces are eachon a 45° angle to reduce the overall size of the nozzle. Fluid behindthe valves is kept separated between the left- and right-hand sides ofthe applicator. Fluid in front of the valves is allowed to mix. 36Umbrella Flexible silicone umbrella valves. These open at a relativelylow fluid pressure, valves in order to minimize the hand squeeze forcerequired. These easy-opening valves are permissible because the BREAZE ™valve assemblies at the applicator inlet block any excess fluid pressurethat is present in the supply hoses. 37 Nozzle rose This is,essentially, a shower head. It has a circle of holes. 38 Nut Holds thenozzle (33) onto the outlet adaptor (31). 39 Tie rods These are longscrews extending from the cover (25), through the barrel (12) (betweenthe two halves) and into the rear handle (5). 40 Handle This steeltorsion spring pushes the front handle (1) away from the rear handlespring (5). The spring coils are in the vicinity of the pivot pins (9,10) at the base of the handles. The handle spring (40) returns theplungers to the forward position, refilling the barrels with fluid forthe next cycle. 41 Elbow This carries the fluid from the outlet tubesthat are integral with the top of the adaptor barrel (12), down to theoutlet tubes (45) that are close to the centerline of the applicator. 42O-ring seal (multiple places) 43 O-ring seal 44 O-ring Holds the O-ringseal (43) in place in the elbow adaptor (41). This allows the retainerbarrel (12) to be readily removed for re-lubrication of the felt washer(28). 45 Outlet tube This carries the fluid from the elbow adaptor (41)forward to the outlet tube connector (32) near the nozzle (33). Itpasses through the inside of the volume control (11) and the housing(7). 46 Screws (multiple places)

Accordingly, an applicator (203) according to the disclosure maycomprise the following: a front handle (1), a plunger engagement pin(2), a spring (3), a knob (4), a rear handle (5), a thread insert (6), ahousing (7), a thread insert (8), a pivot pin (male) (9), a pivot pin(female) (10), a volume control or Dose adjuster (11), a barrelcomponent (12), a fluid inlet (13), a BREAZE™ valve housing (14), adiaphragm (15), an inlet valve (16), an inlet valve retention pin (17),a clamp ring (18), a follower (19), a jumper washer (20), a spring (21),a jet (22), a plug (23), an O-ring seal (24), a rear cover (25), aplunger head (26), a plunger O-ring (27), a felt washer (28), a plungershaft (right hand side) (29), a plunger shaft (left hand side) (30), anoutlet adaptor (31), an outlet tube connector (32), a nozzle (33),gaskets (34), an outlet valve seat (35), an umbrella valves (36), anozzle rose (37), a nut (38), tie rods (39), a handle spring (40), anelbow adaptor (41), an O-ring seal (42), an O-ring seal (43), an O-ringretainer (44), an outlet tube (45), and screws (46).

In a particular embodiment, the parts are arranged according to FIGS.15A-15D. In a particular embodiment, all the parts are connected asindicated in FIGS. 15A-D.

Now that the disclosure has been made, the inventors envision that theapplicator (203) may comprise all the above-recited parts (1-46), or anycombination thereof, including any obvious equivalents thereof, providedthat the applicator functions in substantially the same way as theapplicator depicted in FIGS. 14A-C and 15A-D.

Example 3. Anti-Counterfeiting Measures

In an embodiment, the red part (shown as dark grey in FIG. 23A-B) snapsonto the bottle at the filling plant and cannot be easily removed. Thelong dip tube (semi-rigid) may be supplied separately. If the userwishes to use the bottle inverted, then the dip tube is not used. Foruse with the bottle in the upright position, the user pushes the diptube in through the hole in the red (dark grey in FIG. 23A-B) cap, untilit's in the position shown in the pictures. It is not necessary toremove the red cap. The dip tube cannot be removed once it has beenfitted. The red (dark grey) cap includes a one-way air breather valve.This admits air to the bottle when the fluid is withdrawn. The valveprevents fluid leaking out the vent if the bottle is used inverted.

By preventing air from flowing out from the vent, the valve also makesit more difficult to refill the bottle by pouring liquid in through thefluid outlet. This is particularly true if the dip tube has been fitted.A transit cap (FIG. 23A (I), white, plain flat top) may be used to sealthe fluid outlet and the air vent. This may be removed and re-fitted bythe end user. The white draw-off cap (e.g. FIG. 23A (IV), with the hosebarbs and rotating collar) may be used to connect flexible tubing to thebottle. In particular, this cap has an unusual/non-typical thread sizeand cannot be easily fitted to other bottles.

With the design as-shown, the white draw-off cap (with the hose barbsand rotating collar) must be correctly oriented on the red cap to engagethe fluid and air paths correctly. To make this connection easier andfaster, the fitting action may be modified to a “snap-fit” or “quickrelease” design. These and other obvious connection means may beroutinely engineered by the skilled person, now that the instantdisclosure has been made.

With the design as-shown, the user may remove or cut the flexible tubingthen attach it to some other draw-off cap and bottle. To prevent this,the flexible tube may have a custom profile that cannot be readilyfitted to a standard barbed fitting (without leaking air in). Forinstance, the tube might have flutes on the inner wall, or other similar“copy-defeating” measures. The connector on the white cap may have amatching shape, and may be permanently connected to the tube.

An alternative tubing profile is the “double D,” with two D-shaped tubesformed back-to-back. θ. This shape prevents the two tubes from beingseparated. A custom connector that engages with both sides of the tubeis required. The bottle draw-off cap(s) would likewise be modified tointerface properly with the double D tubes.

Custom tubing of any type requires that the fittings at the applicatorbe likewise customized. For an anti-counterfeiting measure to functionoptimally, the applicator must fit the custom tubing, and only thecustom tubing. This custom fitting at the applicator can also becombined with a “snap-fit” or “quick release” connector design.

If the dip tube is omitted, for use with the bottle/co-packaging in theinverted position, then it is possible for the user to pour replacementfluid (of another brand) down the fluid passage in the red cap. Toprevent this, the dip tube may be fitted at the filling plant. Thismeasure would limit the bottle to upright use only. Upright use may beless likely to result in fluid spills or leaks, and may yield improvedrouting of the tube to the applicator.

In an embodiment, anti-counterfeiting may be achieved by providing anapplicator having two plain holes, aligned with the barrel centerlines,plus a feature to engage a quick-release catch. A plastic adaptorpermanently fitted to the double tube may engage with these holes. Itwill be difficult to fit anything other than the supplied tube andadaptor.

In a rigorous anti-counterfeiting embodiment, the bottles cannot bereadily refilled, as the hose profile (flutes or double-D) makes itdifficult to fit to a normal barbed fitting. Snap-fit connectors at eachend may be fitted to only the disclosed applicator andbottles/co-packaging. There may be restrictions on use, such as uprightbottle use only, no rinsing, etc. In an intermediate anti-counterfeitingembodiment, some, but not all elements of the disclosedanti-counterfeiting measures may be present.

Although this invention has been described by way of example and withreference to possible embodiments thereof, it is to be understood thatmodifications or improvements may be made thereto without departing fromthe spirit or scope of the invention.

The invention will now be described in the following numberedparagraphs.

1.-31. (canceled)
 32. A multi-chamber, multi-liquid delivery applicatorhaving an outlet for delivering at least two liquids, said applicatorcomprising at least two barrels; each barrel comprising: an inlet thatis coupled to one chamber of the dual chamber hose; a one-way valveadjacent to inlet for receiving fluid from the inlet, the one-way valvecomprising means for limiting pressure within a respective barrel; adispensing conduit that is in fluid communication with the one-wayvalve; a piston for displacing fluid through the dispensing conduit; theapplicator further comprising: a mixing chamber coupled to eachdispensing conduit of each barrel for mixing fluid received from eachdispensing conduit to create a mixed liquid, the mixing chamber alsocoupled to the outlet; and an actuator coupled to each piston and formoving each piston within a respective barrel when a force is applied tothe actuator, each piston when moved dispenses the mixed liquid from themixing chamber through the outlet, whereby the applicator provides amechanical advantage in reducing the force needed to actuate theactuator for dispensing the mixed liquid through the outlet.
 33. Theapplicator of claim 32, wherein the pressure limiting means comprises: afirst valve head and a first valve seat, wherein the first valve headcan be moved from a closed position to an open position by movement of adiaphragm; and a second valve head and second valve seat, wherein thesecond valve head is connected to the first valve head and moves withthe first valve head, such that a pressure difference across said firstvalve head is substantially equal to a pressure difference across saidsecond valve head.
 34. The applicator of claim 32, further comprising avolume control for adjusting a fluid volume within a respective barrelreceived from the dual chamber hose.
 35. The applicator of claim 34,wherein the volume control is coupled to the mixing chamber.
 36. Theapplicator of claim 32, wherein the one-way valve comprises a disc. 37.The applicator of claim 36, wherein the disc is coupled to a spring. 38.The applicator of claim 37, wherein the means for limiting pressurecomprises a force transfer component coupled to the spring and a ringhub, and a flexible diaphragm that engages the ring hub and a clampring.
 39. The applicator of claim 32, wherein the actuator comprises afirst handle coupled to a first end of each piston and a second handlecoupled to the mixing chamber.
 40. The applicator of claim 39, furthercomprising a dual chamber hose coupled to the applicator for providingparallel fluid communication to a source of liquid formulation. 41.Packaging for use with the applicator of claim 32, comprising at leasttwo separate containers, each container comprising a different liquidformulation.
 42. The packaging of claim 41, wherein the two containersare coupled together by a fastening device.
 43. The packaging of claim42, wherein the fastening device comprises at least one bracket forholding the two containers together.
 44. The packaging of claim 43,wherein the fastening device comprises two brackets for holding the twocontainers together.
 45. The packaging of claim 41, further comprisinganti-counterfeiting measure(s).
 46. The packaging of claim 41, furthercomprising vented caps.
 47. The packaging of claim 41, furthercomprising dip tubes.
 48. The packaging of claim 45, wherein themeasures comprise non-typical thread size.
 49. The packaging of claim45, wherein the measures comprise snap-fit connectors.
 50. The packagingof claim 45, wherein the measures comprise fluted or double-D hoseprofiles.
 51. The packaging of claim 45, wherein the measures comprise afeature to engage a quick-release catch.